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US 2018/0000954 A1Published application
Modified release formulations containing drug-ion exchange resin complexes
AssigneeTris Pharma, Inc.
InventorsKetan Mehta, Yu-Hsing Tu
Life of this patent
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Abstract
A particulate, modified release barrier coated drug-cation exchange resin complex comprising a core composed of a drug complexed with a pharmaceutically acceptable ion-exchange resin is provided. Methods of making and products containing this coated complex are described.
Claims15
An orally ingestible aqueous liquid suspension comprising:
- (A) barrier coated particulates which provide a modified release profile which comprise:
- (i) a particulate drug-cation exchange resin complex comprising at least one drug bound to a pharmaceutically acceptable water insoluble cation exchange resin, and further comprising a water insoluble polymer or copolymer, or hydrophilic polymer which forms a matrix with the drug-cation exchange resin complex, which particulate drug-cation exchange resin complex-(water insoluble polymer or copolymer or a hydrophilic polymer) matrix is capable of passing through a number 40 mesh screen, and
- (ii) about 25% w/w to about 50% w/w of a water permeable, water insoluble, non-ionic, modified release polymeric diffusion barrier coating which provides a modified release profile to the drug in said drug-cation exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix, wherein said at least one drug is methylphenidate, said barrier coating having an elongation factor of about 125% to about 400% and comprising a water insoluble polymer and about 2.5% w/w to about 20% w/w plasticizer based on the weight of the barrier coating;
- and
- (B) at least one of (iiia) and/or (iiib):
- (iiia) an uncoated particulate methylphenidate-cation exchange resin complex of a size capable of passing through a number 40 mesh screen, wherein said uncoated methylphenidate-cation exchange resin complex is methylphenidate bound to a pharmaceutically acceptable water insoluble cation exchange resin and/or
- (iiib) methylphenidate or a pharmaceutically acceptable salt thereof which is not complexed with an ion exchange resin;
- and
- (C) a pharmaceutically acceptable aqueous suspension base, wherein said barrier coated drug-cation exchange resin complex-matrix as defined in (A) and said at least one additional component (B) are suspended in said base.
6 more elements
An orally ingestible aqueous liquid suspension comprising:
- (A) barrier coated particulates which provide a modified release profile for methylphenidate, which barrier coated particulates comprise:
- (i) a particulate drug-cation exchange resin complex comprising at least one drug bound to a pharmaceutically acceptable water insoluble cation exchange resin, and a water insoluble polymer or copolymer, or a hydrophilic polymer which forms a matrix with the drug-cation exchange resin complex, wherein the particulate drug-cation exchange resin complex-matrix is capable of passing through a number 40 mesh screen, and
- (ii) about 25% w/w to about 50% w/w of a water permeable, water insoluble, non-ionic, modified release barrier coating which provides a modified release profile to the drug in said drug-cation exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix, wherein said at least one drug is methylphenidate, said modified release barrier coating having an elongation factor of about 125% to about 400% and comprising a water insoluble polymer and a plasticizer in an amount of about 2% w/w to about 20% w/w of the barrier coating;
- and
- (B) one or more of (iiia) and/or (iiib):
- (iiia) an uncoated particulate methylphenidate-cation exchange resin complex of a size capable of passing through a number 40 mesh screen, wherein said uncoated methylphenidate-cation exchange resin complex is methylphenidate bound to a pharmaceutically acceptable water insoluble cation exchange resin and/or
- (iiib) methylphenidate or a pharmaceutically acceptable salt thereof which is not complexed with an ion exchange resin;
- and
- (C) a pharmaceutically acceptable aqueous suspension base, wherein said barrier coated drug-cation exchange resin complex-matrix as defined in (A) and said at least one additional component (B) are suspended in said base.
6 more elements
Dependencies are inferred from the claim text.